India Finalizes New Regulations Specifically for Devices

India has finalized new regulations that separate out devices for the first time from broader drug regulations.

Effective on Jan. 1, 2018, the regulations will free device manufacturers from compliance with regulations written for pharmaceuticals. For example, India’s drug regulations mandate four-phase clinical trials, whereas the new device regulations require two-phase trials.

Starting on Jan. 1, 2022, all medical devices sold in India will require a unique device identification (UDI), including a device identifier and a production identifier. A device identifier is a global trade number. A production identifier would include a serial number, lot or batch number, software version, and manufacturing and/or expiration date.

The new regulations specify fees for a variety of licenses and permissions for device importation, manufacturing, clinical investigations, and registration.

Before licenses are granted, notified bodies must audit manufacturing sites in India and must check for compliance with quality management requirements.

Device licenses and registration certificates obtained before the regulations are implemented will remain valid until they expire, or 18 months after implementation, whichever is later, India’s Ministry of Health and Family Welfare said, in a Jan. 31 notice in India’s regulatory Gazette.

The act aims to loosen the FDA’s reigns, but in such vague terms that FDA/industry lawsuits are not only likely, they’re almost inevitable. Devicemaker’s Guide to the 21st Century Cures Act tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes.